Shanghai Easy-Flow Medical Tech Co., Ltd. ("Easy-Flow™") has successfully completed patient enrollment for the clinical trial of its EF-Don™ Drug Coated Hemodialysis Shunt Balloon Dilation Catheter ("EF-Don™ DCB"). This marks a significant milestone in Easy-Flow™'s development of hemodialysis access maintenance solutions.

The prospective, multicenter, randomized controlled trial, which commenced in July 2023, is designed to assess the efficacy and safety of the EF-Don™ DCB in treating arteriovenous fistula (AVF) stenosis among hemodialysis patients. The study is co-led by Prof. Yaxue SHI of LongHua Hospital Shanghai University of Traditional Chinese Medicine, and Prof. Yu ZHAO of The First Affiliated Hospital of Chongqing Medical University. The primary endpoint of the trial is the 6-month Target Lesion Primary Patency (TLPP) rate, with a two-year follow-up period for participants.

EF-Don™ DCB targets the significant challenge of high restenosis rates encountered with conventional balloon angioplasty in the management of vascular access for hemodialysis. EF-Don™ DCB combines high-pressure balloon angioplasty with the localized delivery of the drug paclitaxel, aiming to decrease restenosis rates and, consequently, increase the longevity of vascular access. Results from preclinical studies have demonstrated that EF-Don™ DCB is capable of sustaining therapeutic levels of paclitaxel within the vessel wall for an extended period of over 90 days, indicating its potential for long-term effectiveness.

"The completion of patient enrollment marks a pivotal moment in our endeavor to launch the EF-Don™ DCB," stated Zhenghua Miao, Chairman and General Manager of Easy-Flow™. "This achievement underscores our solution's potential to fulfill the demand for more effective and durable hemodialysis access maintenance treatments. Our commitment is unwavering in offering patients superior treatment options that not only elevate treatment outcomes but also play a role in reducing healthcare expenses."